Events

Alerta De Seguridad para Aequalis Reversed II and Reversed Fracture impactors

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Tornier SAS.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-08-14
  • Fecha de publicación del evento
    2013-08-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130814.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: tornier aequalis reversed ii and reversed fracture impactors medical device manufacturer, tornier sas issued a medical device safety alert concerning all lots of aequalis reversed ii and reversed fracture impactors. the affected item numbers are mwd021, mwd023, mwd024, mwd025. following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, tornier reviewed the event and determined that a redesign of the instrumentation was warranted. the manufacturer initiated a voluntary recall of the product. the recalled instruments will be replaced by a new design in the near future. in the interim, tornier recommends assembling the humeral components and glenoid sphere according to the surgical technical addendum attached with their field safety notice. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 august 2013.

Device

Aequalis Reversed II and Reversed Fracture impactors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Tornier Aequalis Reversed II and Reversed Fracture impactors
  • Manufacturer
    Tornier SAS

Manufacturer

Tornier SAS